The tariff classification of Glatiramer Acetate (CAS no. 147245-92-9) from India

N248290 March 20, 2014 CLA-2-35:OT:RR:NC:2:236 CATEGORY: Classification TARIFF NO.: 3504.00.5000 Mr. Michael R. Tartaro Byron Chemical Company, Inc. 40-11 23rd Street Long Island City, NY 11101 RE: The tariff classification of Glatiramer Acetate (CAS no. 147245-92-9) from India Dear Mr. Tartaro: In your ruling request received November 26, 2013, you requested a tariff classification ruling on Glatiramer Acetate (CAS no. 147245-92-9), product code: R1C83. The U.S. Customs and Border Protection Laboratory has reported that the product at issue is a mixture of synthetic proteins, all composed of four amino acids (alanine, glutamic acid, lysine, and tyrosine) in random order. This product is designed to be used as an immunosuppressant in the treatment of multiple sclerosis. The applicable subheading for Glatiramer Acetate (CAS no. 147245-92-9) will be 3504.00.5000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Peptones and their derivatives; other protein substances and their derivatives, not elsewhere specified or included; hide powder, whether or not chromed: Other. The general rate of duty will be 4 percent ad valorem. This merchandise may be subject to The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which is administered by the Food and Drug Administration (FDA). Information concerning FDA import requirements and regulations can be obtained by contacting the FDA at: Food and Drug Administration, Division of Import Operations and Policy, 5600 Fishers Lane, Rockville, Maryland 20857, Telephone: (888) 463-6332. Information on the Bioterrorism Act can be obtained by calling FDA at (301) 575-0156, or at the Web site www.fda.gov/oc/bioterrorism/bioact.html. This merchandise may be subject to the requirements of the Toxic Substances Control Act (TSCA), which are administered by the U.S. Environmental Protection Agency. Information on the TSCA can be obtained by contacting the EPA at 1200 Pennsylvania Avenue, N.W., Mail Code 70480, Washington, D.C., by telephone at (202) 554-1404, or by visiting their website at www.epa.gov. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/. This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Nuccio Fera at (646) 733-3034. Sincerely, Gwenn Klein Kirschner Acting Director National Commodity Specialist Division